五味消毒饮内服外敷治疗寻常性痤疮35例临床观察

目的:观察五味消毒饮加减内服外敷治疗寻常性痤疮临床疗效。方法:60例痤疮患者随机分为两组,治疗组35例,采用五味消毒饮加减内服外敷联合治疗方法。对照组25例,口服甲硝唑片,睡前外用维A酸乳膏。结果:治疗组痊愈率51.4%,总有效率97.1%;对照组痊愈率24.0%,总有效率80.0%。两组痊愈率与总有效率比较,差异均有显著性(P<0.05)。结论:五味消毒饮加减内服外敷法治疗寻常性痤疮有显著疗效,安全性好。     

Adverse effects of topical anesthetics for dermatologic procedures

Introduction : Topical anesthetics are frequently used to decrease the pain associated with a variety of procedures including cutaneous surgery, cosmetic treatments and laser surgery. They are also routinely used in children prior to invasive procedures, such as venipuncture. The ideal topical anesthetic should safely increase patient comfort associated with these procedures with minimal potential for adverse effects.

Areas covered : Topical anesthetic formulations have evolved over the past several decades to include formulations with improved efficacy and side effect profiles [1 – 3]. However, significant adverse events are still possible.

Expert opinion : Medical practitioners can mitigate the risk of side effects and toxicity with careful selection of anesthetic type, concentration, body location and dermatologic procedure. Compounded formulations should be used with caution in medical settings only on limited body surface areas without occlusion. This review presents a detailed analysis of products available, reported complications and an outline for appropriate use of topical anesthetics in combination with dermatologic procedures.     

Evaluating FMX-101 as a promising therapeutic for the treatment of acne

ABSTRACT

Introduction

Oral minocycline is a mainstay of therapy for moderate-to-severe acne; however, systemic side effects which include hepatotoxicity, lupus-like syndrome, drug hypersensitivity syndrome, autoimmune hepatitis, polyarteritis nodosa, gastrointestinal side effects and skin hyperpigmentation are of concern. Topical antibiotics commonly used in acne, such as erythromycin and clindamycin, present high P. acnes resistance rates which has opened the market for new topical antibiotics. FMX-101 is a novel topical minocycline foam that has shown promising results in phase I, II and III trials for the treatment of moderate-to-severe acne with a better safety profile than oral minocycline.     

The new therapy schema of the various kinds of acne based on the mucosa-skin side effects of the retinoids

The most common adverse effects of oral isotretinoin (>1/10) are: cheilitis, skin dryness, erythema, itching, scaling, bruising, skin atopy, conjunctivitis, dry eyes and eyelid inflammation. The aim of this work was to define an optimal dose regime of the oral isotretinoin allowing for effective reduction of sebum production and minimalization of adverse effects such as decreased skin moisturization, increase in TEWL and intensified erythema. The skin parameters were assessed using the MPA 5 diagnostic apparatus. Moisturization together with an increase in TEWL and erythema during treatment with isotretinoin seem to be crucial factors responsible for patient discomfort. The decrease in the pigment content in the skin during retinoid treatment is a favourable symptom, due to the frequent tendency of skin pigmentation disturbances in the sites after acne changes. On the basis of performed analyses it was concluded that the new therapy schema is the most advantageous form of isotretinoin dosing and it involves the use of a constant drug dose – 0.4–1.0?mg/kg body mass/day without modification during treatment.     

Emerging topical treatments for psoriasis

Introduction: Psoriasis is an immune-mediated chronic inflammatory skin disease which classically presents as erythematous, scaly plaques affecting extensor surfaces of the limbs, scalp and trunk. Approximately 80% of patients have a mild-to-moderate form routinely treated with topical medications, whereas phototherapy, systemic and biological therapies are typically reserved for treatment of moderate-to-severe psoriasis.

Areas covered: The major advances in psoriasis therapy in the past 15 years have been in new immunomodulatory and biological molecules, with a significant unmet need to have new, efficient and safe topical treatment options for the large percentage of patients for whom systemic therapy is not indicated. The available topical therapies (corticosteroids and vitamin D3 analogs) have remained relatively unchanged over the past several decades. This article reviews emerging topical drugs and formulations currently under evaluation in clinical trials.

Expert opinion: The time is right for a revolution in our topical therapy armamentarium. It has lagged significantly behind the systemic biological evolution of new drug development. Our large psoriasis population with mild-to-moderate psoriasis certainly deserves potent but safe and innovative topical agents with a new mode of action as well as with long-lasting clinical efficacy.     

西药结合美容外治法治疗痤疮的临床效果分析

目的应用西药与美容外治法联合方案对痤疮患者进行治疗,分析临床效果。方法抽取86例患有痤疮的临床确诊患者,分为A、B两组,每组43例。分别采用常规西药和常规西药与美容外治法联合进行治疗。结果 B组患者治疗后的病灶改善情况明显优于A组;停止用药和治疗后病灶再次出现的人数明显少于A组;两组治疗过程中没有出现不良反应。结论应用西药与美容外治法联合的方案对痤疮患者进行治疗的临床效果非常明显。     

Safety and side effects of the acne drug,oral isotretinoin

Isotretinoin is a very effective medication for the treatment of severe recalcitrant acne. However, its use is associated with many side effects, some of which can be very serious. The most important issue is its teratogenicity, which has resulted in new pregnancy prevention policies and programmes implemented by the manufacturer. Recently, the association of isotretinoin with depression has been recognised and new guidelines have been adopted for this possible side effect. The most common adverse events, observed during treatment, are mucocutaneous and ophthalmological. In addition, laboratory abnormalities and effects in the nervous, musculoskeletal, gastrointestinal, pulmonary and other systems have been described.     

68例中药注射剂不良反应分析

为了解中药注射剂不良反应发生情况，对我院2003—2005年上报的不良反应报告进行回顾性调查。结果表明中药注射液不良反应主要为过敏反应，表现对皮肤附件、胃肠道、中枢及外周神经系统、心血管系统、呼吸系统等损害。中药注射液不良反应应引起临床重视。     

胶原贴敷料联合面部外治法治疗寻常险匮唐蝴析

目的观察胶原贴敷料联合面部外治法治疗寻常型痤疮的疗效和安全性。方法将150例寻常型痤疮患者随机分成两组,治疗组75例,对照组75例。治疗组和对照组均给予面部外治法,每周1次,同时予罗红霉素缓释胶囊0．3g,qd,VI服;甲硝唑0．2g,Bid,口服,治疗组同时给予胶原贴敷料每晚1次,连用1周,然后改为隔日1次,疗程共8周。于治疗前、治疗4周、治疗8周分别观察患者的皮损情况、色素沉着情况、皮脂溢出情况及不良反应。结果治疗组有效率为95．83％,对照组94．66％,皮损综合情况疗效比较差异无统计学意义,但是,治疗后皮脂溢出情况、色素沉着情况较对照组差异有统计学意义,两组均未见明显不良反应。结论胶原贴敷料苷联合面部外治法治疗寻常型错痤疮疗效好、安全。且胶原贴敷料能明显改善面部油脂溢出和面部痤疮后色素沉着。     

Managing patients with side effects and adverse events to immunoglobulin therapy

Immunoglobulin therapy has not only served as a lifesaving approach for the prevention and treatment of infections in primary and secondary immunodeficiency diseases, but has also been used as an immunomodulatory agent for autoimmune and inflammatory disorders and to provide passive immunity for some infectious diseases. Most of the adverse effects associated with immunoglobulin therapy are mild, transient and self-limiting. However, serious side effects also occur. Therefore, to minimize the adverse events of immunoglobulin therapy, specialist review of patient clinical status and immunoglobulin products, in addition to selection of appropriate treatment strategy for the management of patients with associated side effects and adverse events, are crucial.     

乳腺癌辅助化疗及激素治疗的药物不良反应

目的：了解乳腺癌辅助化疗及激素治疗的药物不良反应。方法：查阅文献进行综述。结果：辅助治疗的主要不良反应是可逆的。结论：对早期浸润性乳腺癌妇女，使用辅助治疗还是有益的。     

红蓝光交替照射结合系统服药治疗寻常性痤疮疗效观察

目的探讨药物和红蓝光结合治疗寻常性痤疮的疗效和安全性。方法选择本院门诊痤疮患者104例,随机分为两组,对照组（50例）给予药物治疗,治疗组（54例）在药物治疗基础上结合红蓝光治疗,疗程为4周。结果治疗组患者有效率为81．48％,对照组有效率为48．00％,治疗组有效率显著高于对照组（P〈0．01）。结论系统服药结合红蓝光治疗寻常性痤疮安全、有效,值得临床借鉴和推广应用。     

Suboptimal reporting of adverse medical events to the FDA Adverse Events Reporting System by nurse practitioners and physician assistants

Objectives: The Adverse Events Reporting System (AERS) of the FDA is used to identify toxicities of drugs that are on the market. Nurse practitioners (NP) and physician assistants (PA), having an increasing role in the delivery of medical care, are also needed to participate in post-marketing pharmacovigilance. This study was performed to assess awareness and use of the AERS in voluntary reporting of drug toxicities by NPs and PAs.

Methods: A cluster sample survey was issued at the Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course in August 2010. The survey assessed familiarity with the AERS, the number of adverse events seen and the frequency of reports sent to the AERS. NP and PA responses were compared using the two-tailed Fisher's exact.

Results: Of the 92 respondents, 67 (72%) were NPs and 24 (26%) PAs. Of the 50 (54%) respondents that reported being familiar with the AERS system, 20 (40%) incorrectly identified the methods to report using the AERS. Overall reporting of adverse events was low, particularly in respondents seeing 5–12 adverse events per year.

Conclusion: The study suggests that improved education regarding the importance of using AERS for pharmacovigilance is suggested for NPs and PAs. Due to the small size of the study, these data should be viewed as preliminary, pending a larger confirmatory study.     

A new approach to comparing efficacy results from clinical trials of topical acne vulgaris treatments

Clinicians must evaluate a voluminous amount of information from clinical trials when choosing among the growing number of topical acne treatments. This article describes a simple way to evaluate and broadly compare the efficacy results of well-controlled phase III clinical trials of topical acne treatments by taking into account the placebo effect (or active control effect). Key efficacy results are drawn from the package inserts of 7 primary topical acne treatments. To account for placebo effect, the mean percent reduction with placebo was subtracted from that of the active treatment for each type of lesion and also calculated as an average of these differences for all lesions. Based upon the principles of research, this method accounts for within study variances and offers a quick assessment of product efficacy. Clinicians should be cautioned that this method only allows for broad comparisons and does not establish definitive differences between treatments.     

全面触发工具在药品不良事件检测中的应用初探

目的：探讨全面触发工具（ GTT）在我国医疗机构检测药品不良事件（ ADE）的可行性。方法调取1013年1月1日至11月31日首都医科大学宣武医院出院患者的信息,按照出院时间排序后,使用Microsoft Excel 1007软件中的随机抽样工具,每半个月随机抽取30例患者的病历。根据入选标准（患者年龄≥18岁,1013年住院次数为1次,住院时间﹥1 d）、排除标准（入住产科、计划生育科、康复科、肿瘤科、日间病房、儿科的患者）剔除不合格病历,使用GTT推荐以及根据国外相关研究和首都医科大学宣武医院自身经验确定的35项触发器（包含实验室指标、解救剂、临床症状和处理措施等）按样本随机顺序每半个月审查10份病历（若符合入选标准者不足10份则全部纳入）,检测到触发器者标记为触发器阳性,对触发器阳性所涉及情况进一步审查以确定或排除 ADE,对确定为ADE者进行分级。使用Microsoft Excel 1007软件对阳性触发器和ADE进行整理分析,计算阳性触发器的阳性预测值。结果审查病历共465份,涉及465例患者,其中男性156例,女性109例,年龄19~91岁,平均57岁,住院时间1~37 d,平均10 d。465例患者中触发器阳性者108例（44.7%）。35项触发器中有11项触发器呈阳性（61.9%）,共检出341例次。确定ADE 18例次,涉及16例患者,ADE检出率为3.4%（16/465）。18例次ADE中13例次有相对应的触发器,涉及8项触发器。11项阳性触发器的总体阳性预测值为3.8%。18例次ADE包括肺炎、肝损伤、寒战和皮疹各1例次,抗菌药物相关性腹泻、头痛、头晕、恶心呕吐、低血糖、过度镇静、谵妄、出血、白细胞减少症和兴奋各1例次;14例次为E级,4例次为F级;涉及药物11种,包括抗菌药物5种,血液系统药物和精神系统药物各3种,心血管系统药物、激素类药物和中成药各1种,调脂药、影响骨代?     

与使用喜炎平注射液相关的药品不良事件个例分析

目的:提高医疗技术水平,保障人体安全用药。方法:对在临床中观察到的喜炎平注射液相关药品不良事件个例进行分析、讨论。结果:药品不良事件的分析需要考虑到临床中的多种混杂因素的干扰。结论:广大医务人员要重视个例药品安全性事件的报道和分析,为合理、安全用药提供参考。     

Treatment-emergent adverse events associated with atypical antipsychotics

Introduction: Atypical antipsychotics provide broad-spectrum effectiveness for the acute and/or preventative treatment of disparate psychiatric disorders. Atypical antipsychotics offer improved efficacy in some psychopathological domains when compared with typical antipsychotics. Notwithstanding, atypicals are not a catholicon and are associated with clinically significant and treatment-limiting side effects (e.g., extrapyramidal symptoms and weight gain).

Areas covered: This article reviews commonly encountered adverse events attributable to the use of atypical antipsychotic agents. This review aims to provide a current overview of common adverse events associated with atypical agents with a particular emphasis on adverse events that frequently lead to treatment discontinuation (e.g., changes in weight, metabolism, extrapyramidal side effects, neuroendocrine changes, blood dyscrasias, and cardiovascular toxicity).

Expert opinion: Atypicals are not a catholicon and are associated with clinically significant and treatment-limiting side effects (e.g., extrapyramidal symptoms and weight gain). Improving the utility of these agents requires a familiarity and understanding of the heterogeneous tolerability and safety profiles of atypical agents as well as the therapeutic evidence for their efficacy.     

润燥止痒胶囊联合维A酸乳膏治疗寻常痤疮疗效观察

目的 研究润燥止痒胶囊联合维A酸乳膏治疗寻常痤疮的疗效.方法 76例寻常痤疮门诊患者随机分成2组,治疗组38例,口服润燥止痒胶囊,2g/次,3 次/d,同时每晚外用0.025％维A酸乳膏,对照组38例,仅每晚外用0.025％维A酸乳膏,疗程均为4周.结果 治疗组有效率为86.84％,对照组为65.79％.两组比较差异有统计学意义(x2=4.66,P＜0.05).治疗组有3例,对照组有4例出现轻度皮肤刺激症状,未影响治疗.结论 润燥止痒胶囊联合维A酸乳膏治疗寻常痤疮安全有效,具有较好的协同作用.     

维胺酯治疗痤疮类皮肤病的临床观察

<正> 维甲酸类(retinoids)在皮肤科临床上的应用,即在痤疮、银屑病、各种角化异常性皮肤病以及某些癌前或癌性疾病的治疗上,均取得了令人鼓舞的治疗效果。口服维甲酸类药物在皮肤科的应用,已有较详细的介绍。本文就国产维甲酸类衍生物维甲酯在痤疮类皮肤病中的疗效及其毒副作用作以下介绍。维胺酯的化学名称为N-(4-氧碳基苯基)维生素甲酰胺N-(ethoxycarbephenyl)-retinamide。分子式C_(29)H_(37)NO_3其化学结构式如下。     

Clindamycin phosphate/tretinoin gel formulation in the treatment of acne vulgaris

Clindamycin phosphate 1.2% together with tretinoin 0.025% as a gel (CTG) is a topical formulation of a fixed and stable combination approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. The main indication of CTG is the management of moderate comedonal and mild-to-moderate papulopustular acne, an acne form which is present in more than 50% of acne patients. CTG can also be combined with systemic antiacne therapy, such as systemic isotretinoin, in nodulocystic acne. The product combines the anti-inflammatory and antibacterial properties of clindamycin with the well proven and beneficial comedolytic and anticomedogenic effects of tretinoin (all-trans retinoic acid). The addition of clindamycin to tretinoin enhances the comedolytic efficacy of tretinoin in moderate-to-severe acne of the face. The comedolytic activity of tretinoin and the anti-inflammatory efficacy of clindamycin accelerate resolution of all types of acne lesions without affecting the safety of both compounds. Discontinuation rates due to adverse events related to this formulation were found to be low (≤ 1%). Safety of CTG use in pregnancy has not been established. The combination formulation is mainly designed to enhance effectiveness and minimize irritation. The once daily use of CTG, its rapid and dual effect and good tolerability have a positive impact on the duration of disease, patients' compliance and overall costs of therapy.